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Adequate Duration of Antibiotic Treatment in Community-acquired Pneumonia With High Risk Class and Adequate Initial Clinical Response

NCT03609099 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2019-12-05

No results posted yet for this study

Summary

Non-inferiority, multicenter, prospective double-blind, randomized clinical trial of two parallel groups. The randomization between the 2 study groups will be carried out according to a scheme generated by a computer program, in blocks of 6 and stratified by centers. The antibiotic treatment will be evaluated during 5 days compared to the usual antibiotic treatment for more than 7 days in patients with community-acquired pneumonia with a Pneumonia Severity Index IV-V severity score who present an adequate response in the first 4 days of hospital antibiotic treatment.

Conditions

  • Community-acquired Pneumonia

Interventions

DRUG

Moxifloxacin

400 mg / day once a day oral treatment during 3 days.

DRUG

Placebo

once a day oral treatment during 3 days.

Sponsors & Collaborators

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

  • Miquel Ferrer - Investigator Coordinator

    collaborator UNKNOWN

  • David Garcia Cinca

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2020-11-15
Completion
2021-05-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03609099 on ClinicalTrials.gov